Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection) (RE-VIEW)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Age - Related Macular Degeneration (AMD)

Treatments: Drug: Intravitreal Aflibercept Injection (IAI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01722045

VGFTe-AMD-1124

Details and patient eligibility

About

This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.

Enrollment: 154 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria include but are not limited to:

1. Men or women great than or equal to 50 years of age with unilateral neovascular AMD
2. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
4. The CNV area must be at least 50% of total lesion size
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent
7. Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion criteria include but are not limited to:

1. Neovascular AMD in the fellow eye
2. Corneal endothelial measures as judged by an independent reading center
3. Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
4. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
5. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
6. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
7. Contact lens wear in either eye within 6 months of screening
8. History of angle closure glaucoma in either eye
9. Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
10. History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
11. Any prior ocular trauma (blunt or penetrating) in either eye
12. Embedded corneal foreign body in either eye
13. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
14. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
15. Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
16. Any prior use of amantadine
17. Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
18. Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
19. Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)
20. Current treatment with systemic anti-VEGF therapeutics at screening
21. Known serious allergy to the fluorescein sodium for injection in angiography
22. Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
23. Positive serum hCG pregnancy test at the screening visit

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

Open label IAI

Experimental group

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)